Static Graviceptive Functions in Patients With Cervical Dystonia (CD)
Experimental Pilot Trial Assessing Static Graviceptive Function in Patients With Cervical Dystonia
Study Overview
Status
Conditions
Detailed Description
Background:
The pathophysiological mechanism of cervical dystonia remains unclear. Affection of static graviceptive function has been shown in these patients by measuring the Subjective Visual Vertical (SVV). Healthy subjects, tested with voluntary head tilt, would tilt SVV in the opposite direction of the head. (Müller "E" effect), whereas patients with cervical dystonia set SVV close to true upright with a minimal deviation toward head-tilt. The mechanism of this change in otolith activity in patients with cervical dystonia is still unknown. When treated with botulinum toxin, head deviation will be reversed during a period of approximate 6-9 weeks, with a first peak of action after approximate 3 weeks.
Aim
The aim of this study is to investigate the effect of normalization of the head position under routine intramuscular botulinum toxin application in the cervical muscles (screening, 3 weeks and 9 weeks after injection) on static graviceptive function in patients with cervical dystonia.
Rationale
To our knowledge, the effect of botulinum toxin therapy on static otolith function in patients with cervical dystonia has never been evaluated. This study may provide new informations on the neural plasticity of the vestibular system and may contribute to the understanding of pathophysiological mechanisms of cervical dystonia. Accordingly, it may help developing new treatment strategies for this disease.
Primary hypothesis
There is a difference of at least 6 degrees in subjective visual vertical of patients with CD tested in habitual head position at study inclusion and 3 weeks after injection of Botulinum Toxin.
Study design
Subjective visual vertical will be tested in Patients with CD, who are pre-treated with botulinum toxin and show a good treatment response.
Patients SVV will be assessed before routine botulinum toxin injection (on day of injection), 3 and 9 weeks after injection. For control, SVV will be assessed in normal subjects.
SVV assessment
SVV will be performed by the patient and control while sitting upright in a dark room in different head positions, the head is fixed using a head holder.
In CD patients, SVV will be assessed in different head positions:
- the habitual head deviation (head deviation will be classified by Tsui score),
- head fixed in neutral head position (defined as 0° or no head rotation).
- ear deviated 15° and 30° to ipsilateral and contralateral side, respectively, starting at habitual head deviation
SVV in normal subject, with
A) head fixed in neutral position (defined as 0° or no head rotation),
B) ear deviated 30° to the left,
C) ear deviated 30° to the right,
D) ear deviated 15° to the left,
E) ear deviated 15° to the right, will be assessed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Department of Neurology, Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Idiopathic CD and willing to participate on the study,
- Isolated laterocollis or laterocollis and torticollis with maximum of 15°rotation
- Aged 18-80 years,
- Under routine treatment with botulinum toxin
Exclusion Criteria:
Patients and Control
- History of vestibular disorders
Patients
- Torticollis with >15°rotation
- Secondary CD (structural MRI lesions, Mb. Wilson)
- Contraindication for intramuscular botulinum toxin therapy: bleeding disorder or anticoagulation therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Cervical dystonia
patients suffering from cervical dystonia under routine botulinum toxin treatment |
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healthy volunteers
control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective visual vertical (SVV), measured in degree (°)
Time Frame: screening
|
Assessment: sitting upright in dark room, head is fixed using a head holder with a strap and a neck rest covering the occiput and posterior neck.
For deviation of head (0°, 15° and 30° to the left and right side), head holder can be rotated about its midpoint.
In front of patient (distance of 100 cm) is dim light bar, which can be rotated about its midpoint by means of an electronic motor and a remote control device.
Patients adjust bar for parallel alignment with the perceived gravitational vertical.
The operator tilts the bar in a random order 18° from the physical vertical.
|
screening
|
|
SVV in degree (°)
Time Frame: 3 weeks after screeening
|
Assessment: sitting upright in dark room, head is fixed using a head holder with a strap and a neck rest covering the occiput and posterior neck.
For deviation of head (0°, 15° and 30° to the left and right side), head holder can be rotated about its midpoint.
In front of patient (distance of 100 cm) is dim light bar, which can be rotated about its midpoint by means of an electronic motor and a remote control device.
Patients adjust bar for parallel alignment with the perceived gravitational vertical.
The operator tilts the bar in a random order 18° from the physical vertical.
|
3 weeks after screeening
|
|
SVV in degree (°)
Time Frame: 9 weeks after screening
|
Assessment: sitting upright in dark room, head is fixed using a head holder with a strap and a neck rest covering the occiput and posterior neck.
For deviation of head (0°, 15° and 30° to the left and right side), head holder can be rotated about its midpoint.
In front of patient (distance of 100 cm) is dim light bar, which can be rotated about its midpoint by means of an electronic motor and a remote control device.
Patients adjust bar for parallel alignment with the perceived gravitational vertical.
The operator tilts the bar in a random order 18° from the physical vertical.
|
9 weeks after screening
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of head deviation (°)
Time Frame: screening
|
head deviation of patients group in relaxed posture, measured in degrees (°)
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screening
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degree of head deviation (°)
Time Frame: 3 weeks after screening
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head deviation of patients group in relaxed posture, measured in degrees (°)
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3 weeks after screening
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degree of head deviation (°)
Time Frame: 9 weeks after screening
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head deviation of patients group in relaxed posture, measured in degrees (°)
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9 weeks after screening
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Vacherot F, Vaugoyeau M, Mallau S, Soulayrol S, Assaiante C, Azulay JP. Postural control and sensory integration in cervical dystonia. Clin Neurophysiol. 2007 May;118(5):1019-27. doi: 10.1016/j.clinph.2007.01.013. Epub 2007 Mar 23.
- Bove M, Brichetto G, Abbruzzese G, Marchese R, Schieppati M. Neck proprioception and spatial orientation in cervical dystonia. Brain. 2004 Dec;127(Pt 12):2764-78. doi: 10.1093/brain/awh291. Epub 2004 Sep 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVV_CD1
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